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舌象仪临床应用研究的方法学及报告质量评价
Methodology and report quality evaluation for clinical application of tongue imager
投稿时间:2019-03-27  修订日期:2019-04-12
DOI:
中文关键词:  舌象仪  临床应用  质量评价  CONSORT  STROBE  
英文关键词:Tongue instrument  Clinical application  Quality evaluation  The CONSORT.STROBE.
基金项目:国家重点研发计划中医药现代化研究重点专项(2017YFC1703305):中医舌象诊断规范与标准研究及应用
作者单位E-mail
关媛媛 天津中医药大学 gyy19900507@163.com 
庄淑涵 天津中医药大学  
田春颖 天津中医药大学  
孙璇 天津中医药大学  
田之魁 天津中医药大学  
王泓午 天津中医药大学 tjwanghw55@163.com 
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中文摘要:
      目的评价舌象仪临床应用研究的随机对照试验(RCT)、病例系列研究的方法学及报告质量。方法:检索PubMed、CBM、CNKI、VIP和WanFang Data数据库,检索时间均从建库截至2018年12月,收集应用舌象仪观察临床疾病的RCT、病例系列研究和病例对照研究,分别参考Cochrane手册5.1.0版的偏倚风险评估工具和CONSORT声明2010版,评价纳入RCT的方法学和报告质量;分别参考NICE病例系列研究质量评价标准和STROBE声明第四版评价纳入病例系列研究的方法学和报告质量评价。结果:初检出相关文献567篇,最终纳入59篇文献,包括2个RCT,57个病例系列研究。Cochrane偏倚风险工具评价结果显示:50%的RCT采用了较为合理的随机分配方法,都未采用分配隐藏和盲法;100%的RCT采用了意向治疗(ITT)分析却不清楚是否存在失访;研究均无选择性报告。CONSORT声明2010版评价结果显示:文献均不能从文题识别是随机临床试验;样本含量计算、随机化实施细节、流程图的使用、结果分析类型、试验注册及方案等的报告率均为0。NICE病例系列研究质量评价结果显示:纳入病例系列研究中仅14.04%符合多中心研究;59.64%的研究纳入排除标准不明确;均未做到连续招募患者和使收集的数据达到预期目标,也均未做到分层分析结局。STROBE声明评价结果显示:纳入的病例系列研究均未在题目中明确注明是病例系列研究;研究设计、样本大小、受试者流程、偏倚、局限性、可推广性的报告率均为0。结论舌象仪临床应用的RCT、病例系列研究和病例对照研究的报告质量较差,研究存在不同程度的方法学问题,建议今后在设计和报告RCT、病例系列研究分别参考CONSORT声明、STROBE声明,以提高研究质量,增强舌象仪临床应用于疾病效用证据的强度,推进中医的客观化和现代化。
英文摘要:
      Objective To evaluate the randomized controlled trial (RCT) of clinical application of tongue imager, the methodology of case series study and the quality of report. METHODS: PubMed,CNKI, VIP, and WanFang databases were searched. The database was searched from December 2018, and RCT, case series, and case-control studies were performed using tongue images to observe clinical disease. Refer to Cochrane Manual 5.1. Version 0 of the Risk Assessment Tool and the CONSORT 2010 version of the statement, the methodological and reporting quality of the included RCT study was evaluated; and the methodological quality evaluation study of the methodology was conducted according to the fourth edition of the NICE and STROBE Statement.RESULTS:567 related literatures were initially detected and 59 were included, including 2 RCTs and 57 case series studies. 50% of the RCTs used Cochrane Bias Risk Tool to evaluate showed that the random allocation method was reasonable and did not use allocation concealment and blind method. Intentional Therapy (ITT) analysis was used, unfortunately, no missing interviews were reported, and there was no selective report in the study. The quality evaluation results of NICE case series studies: only 14.04% of the case series studies met the multi-center study; 59.64% of the studies included in the exclusion criteria were not clear; the data did not meet the expected set goals and did not carry out stratified analysis. The evaluation results of the 2010 edition of CONSORT statement showed that the included literature could not distinguish whether it was a randomized clinical trial or not, and the reporting rate of multiple items was 0. The results of evaluation with STROBE statement showed that all the included case series studies were not clearly identified as case series studies in the title, and the reporting rate of multiple items was 0. Conclusion The RCT and case series of clinical reports on tongue imaging are of low quality. It is recommended to refer to the CONSORT statement and the STROBE statement when designing and reporting clinical case-control and randomized controlled trials to correct the current methodological problems and further improve clinical research. Quality, enhance the intensity of clinical application of tongue imager in clinical efficacy, and promote the objectification and modernization of Chinese medicine.
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